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This is a pilot study, which will include approximately five eyes of 5 patients. This study proposes that a sustained release steroid insert (Yutiq)1 be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery. The primary aim of this study is to assess the safety and efficacy (controlling intraocular pressure) of the Yutiq inserts to reduce post-operative scarring in surgical glaucoma patients. It is expected that post-operative week 12 onwards there will be a clinically and statistically significant lower IOP in the study eyes than eyes in a group undergoing the same surgery without the Yutiq insert. The estimated duration of the present study is 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yutiq | Experimental | A sustained-release steroid insert (Yutiq) will be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery. |
|
| Control | No Intervention | Non-study eye will not receive the Yutiq insert |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yutiq 0.18 MG Drug Implant | Drug | a sustained-release steroid insert (Yutiq) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in IOP measured using Goldman applanation tonometry | IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert | week 12, month 6, month 12, month 18, month 24, month 30 , month 36 |
| Change in IOP measured using tonopen/Icare | IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert | week 12, month 6, month 12, month 18, month 24, month 30 , month 36 |
| Medications usage as measured by medical record abstraction | Number of medications to control IOP in the study eye | week 12 |
| Medications usage by medical record abstraction | Number of medications to control IOP in the study eye | month 6 |
| Medications usage by medical record abstraction | Number of medications to control IOP in the study eye | month 12 |
| Medications usage by medical record abstraction | Number of medications to control IOP in the study eye | month 18 |
| Medications usage by medical record abstraction | Number of medications to control IOP in the study eye | month 24 |
| Medications usage by medical record abstraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Asrani, MD | Duke Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| D004343 | Drug Implants |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Number of medications to control IOP in the study eye |
| month 30 |
| Medications usage by medical record abstraction | Number of medications to control IOP in the study eye | month 36 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | week 12 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | month 6 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | month 12 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | month 18 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | month 24 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | month 30 |
| Days on Steroid therapy by medical record abstraction | Total number of days of topical steroid therapy postoperatively | month 36 |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |